PeptidePedia The community reference

Cold-chain freight (revision 3)

Old revision·17:21, 3 Nov 2024·CustomsClarke

This is an old revision of this page, as it stood at 17:21, 3 Nov 2024, saved by CustomsClarke with the summary add the reconstitution-stability sentence with its storage condition. It may differ substantially from the current revision, and any error it contains may since have been corrected.
Cold-chain freight
Passive systemsInsulation plus phase-change material
Active systemsPowered refrigeration
Evidence of performanceA temperature record, not a cold pack
Topic infobox · conventions

Cold-chain freight is transport under controlled temperature. For peptides it is used to limit the degradation routes — deamidation, oxidation, aggregation — whose rates rise with temperature, and its performance is a matter of record rather than of appearance.[1]

A passive shipper is insulation plus a phase-change material, designed to hold a temperature range for a stated duration under a stated ambient profile. It does not hold indefinitely, and a shipment that takes longer than the design duration is outside the qualification whatever the pack looks like on arrival.[2]

Passive and active systems

[edit]

Passive shippers are qualified by testing against defined ambient profiles: a summer profile, a winter profile, and a duration. Qualification states what the system will do under those conditions, and nothing about what it will do outside them.[2]

The coolant matters. Gel packs conditioned to refrigerator temperature hold a chilled range; frozen packs can take contents below the intended range, and freezing is a distinct hazard for a solution. Phase-change materials formulated to melt at the target temperature avoid both extremes.

References

  1. ^ International Council for Harmonisation, Q1A(R2): Stability Testing of New Drug Substances and Products (2003).
  2. ^ a b United States Pharmacopeia, General Chapter <1079>, Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products.